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| Name | Class |
|---|---|
| Lumen Biomedical | INDUSTRY |
| Prairie Education and Research Cooperative | INDUSTRY |
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To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment, Open label, Single Group Assignment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumen Biomedical FiberNet Embolic Protection System | Device | to demonstrate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System during the performance of primary renal stenting in the treatment of pts with a high grade ostial atherosclerotic renal lesion(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis. | Various secondary endpoints evaluated at 30 days and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System | most at 30 days and 6 months |
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Inclusion Criteria:
Age ≥ 18 and ≤ 85 years.
Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB approved consent form.
Subject understands the duration of the study and it's follow up visit requirements.
Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following:
Angiographic Inclusion Criteria
Exclusion Criteria:
Clinical Exclusion Criteria
Angiographic Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIVA Physicians Inc. | San Jose | California | 95123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21805607 | Derived | Laird JR, Tehrani F, Soukas P, Joye JD, Ansel GM, Rocha-Singh K. Feasibility of FiberNet(R) embolic protection system in patients undergoing angioplasty for atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):430-6. doi: 10.1002/ccd.23292. Epub 2011 Dec 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 24, 2015 | |
| Reset | Sep 22, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 24, 2015 | Sep 22, 2015 |